FDA Calendar Updates: Diabetes

Includes: AZN, BMY, NVO, TKPHY
by: Mike Havrilla

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars.

The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
1.) Bristol-Myers (NYSE:BMY) and AstraZeneca (NYSE:AZN): The PDUFA decision date for the Onglyza (saxagliptin oral tablets) (a dipeptidyl peptidase-4 or DPP-4 enzyme inhibitor for Type 2 Diabetes) was extended by three months today by the FDA for a new deadline of 7/30/09. On, 4/1/09 a FDA Advisory Panel (the Endocrinologic and Metabolic Drugs Advisory Committee) voted 10-2 that clinical data rule out the risk that the drug hastens heart attack, stroke and other problems.
Below are two related companies with pending FDA decisions for similar types of diabetes drugs.
2.) Takeda Pharma (OTC:TKPHY): alogliptin (SYR-322) NDA - Type 2 Diabetes. Although the alogliptin NDA was filed prior to issuance of FDA's December 2008 guidance on new Type 2 diabetes treatments, the FDA will apply these guidelines when reviewing the alogliptin NDA. Additionally, the FDA does not believe that the amount of existing alogliptin clinical data is sufficient to meet certain statistical requirements in the new guidance. The agency is open to discussions regarding the design of additional cardiovascular (CV) studies with alogliptin.
Alogliptin's Prescription Drug User Fee Act (PDUFA) date - June 26, 2009 - remains unchanged. In December, 2008 the FDA issued "Guidance for Industry: Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes". In October 2008, Takeda received notification from the FDA that it was unable to complete its review of the alogliptin NDA by the original PDUFA date -- October 27, 2008 -- due to internal resource constraints.
The FDA did not raise any issues with the data in the alogliptin NDA at that time. In December 2007, Takeda submitted its NDA for alogliptin to the FDA. Alogliptin, which was discovered by Takeda's wholly owned U.S. subsidiary, Takeda San Diego, Inc. is a dipeptidyl peptidase IV (DPP-4) inhibitor being reviewed as an adjunct to diet and exercise for the treatment of type 2 diabetes. Takeda also has a PDUFA decision date of 7/23/09 for its Alogliptin (SYR-322) + Actos (pioglitazone) NDA for a combination tablet to treat Type 2 Diabetes
3.) Novo Nordisk (NYSE:NVO): Victoza (liraglutide) NDA for Type 2 Diabetes. (Original PDUFA date was 3/23/09). Victoza (liraglutide) is used once-daily via subcutaneous injection. Liraglutide is a synthetic glucagon-like peptide-1 (GLP-1) and is classified as an incretin mimetic type of diabetes drug. On 4/2/09, an FDA Advisory Panel stated liraglutide does not appear to carry heart risks, though serious questions remain about its links to tumors. Panelists were split, voting 6-6, on whether the drug should be approved in the face of evidence it caused cancerous thyroid tumors in rats and mice. The panel voted 8-5 that liraglutide did not appear to hasten heart attack and other problems seen with similar drugs in recent years.
Disclosure: No positions.